MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE

Model Number	DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding falsely depressed sodium (na) and total bilirubin (tbi) results obtained on one patient sample on a dimension® exl¿ with lm integrated chemistry system and sample transfer module.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.The instrument data indicated improper sample aspiration for sample id 221650403co.The event was isolated to sample id 221650403co.Quality control was within laboratory ranges.A potential product issue was not identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant falsely depressed sodium (na) and total bilirubin (tbi) results were obtained on one patient sample on a dimension exl w/lm stm system.The discordant results were not reported to the physician(s).The same sample was reprocessed on an alternate dimension system and higher results, considered correct, were obtained and reported.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed results.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC. BROOKFIELD; registration number 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 14976459
• Report Number: 2517506-2022-00175
• Device Sequence Number: 5690382
• Product Code: JJE
• UDI-Device Identifier: 00630414593593
• UDI-Public: 00630414593593
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE
• Device Catalogue Number: SMN 10639337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown